MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-18 for RESERVOIR 44111 VENTRICULAR BURR HOLE manufactured by Medtronic Neurosurgery.
[97732323]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[97732324]
It was reported that on (b)(6) 2017, the patient has a neurosurgical examination and mild redness around the surgical area was noted. The following day, laboratory testing was conducted that included cerebrospinal fluid (csf) testing that resulted in gram positive on cocci clusters stain. Another csf sample was drawn from the ommaya that was implanted on (b)(6) 2017. C-reactive proteins (crp) were noted as normal. During an infusion on the same day, the patient continued to have mild redness around the surgical area. Following the infusion, it was noted that the patient had an elevated white blood cell count (wbc) (140) so additional tests were performed that included a full blood count (cbc) and a csf testing; the cbc was normal and results of the csf testing were not provided. The elevated wbc was later updated to meningitis staphylococcal. On (b)(6) 2017, the patient experienced seizures during an infusion. An hour later, the patient developed a fever of 103? F and some irritability so a repeat csf sample was taken (b)(6) and showed an increased csf-wbc of 140. Intravenous (iv) ceftriaxone/vancomycin were administered for 14 days. The ommaya device was then tested and it was confirmed that it was negative staphylococcus aureus; however, it was decided to surgically remove the product on an unknown date. During the removal, a subgaleal collection of pus from the wound was noted. A swab was taken from the collection and it tested positive for staph. On (b)(6) 2017, the patient experienced "tight fisting" with abnormal posture of the hands. The following day, the patient experienced a fever, abnormal posturing of the feet, full body myoclonic jerks, and neck rigidity so the antibiotics were shifted to nafcillin. On (b)(6) 2017, the culture results and the csf from a lumbar puncture showed negative results. An mri of the patient's brain was then performed and showed signs of meningitis and ventriculitis, but no abscess was noted. It was then reported that in addition to the previously reported adverse events, the patient also lost their ability to swallow, which required an insertion of a nasogastric (ng) tube. Clobazam was then administered on (b)(6) 2017. On (b)(6) 2017, the patient was discharged from the hospital. The event was considered resolved with sequelae on an unknown date; the sequelae was noted as "jerks".
Patient Sequence No: 1, Text Type: D, B5
[101969170]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101969171]
Additional information was received from a health care provider (hcp) regarding a patient whose indications for use included batten's disease. It was reported that there were no issues with the device noted on the surgical report. It was noted, however, that the patient experienced a change in mental status with seizures. It was also noted that following the explant a culture was taken and resulted in staphylococcus aureus - oxacillin susceptible; the report was finalized on (b)(6) 2017. Following the explant procedure, the patient was taken to the intensive care unit in a serious, but stable condition. When inquired about any environmental / external / patient factors that may have led or contributed to the issue, it was reported that it was unclear. The health care provider (hcp) suspected it was related to wound healing from the initial implant procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00028 |
| MDR Report Key | 7204136 |
| Date Received | 2018-01-18 |
| Date of Report | 2018-03-02 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-02-07 |
| Date Added to Maude | 2018-01-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESERVOIR 44111 VENTRICULAR BURR HOLE |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | JXG |
| Date Received | 2018-01-18 |
| Model Number | 44111 |
| Catalog Number | 44111 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Brand Name | RESERVOIR 44111 VENTRICULAR BURR HOLE |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR |
| Product Code | LKG |
| Date Received | 2018-01-18 |
| Model Number | 44111 |
| Catalog Number | 44111 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2018-01-18 |