N
Patient 1
PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2020. PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9885604
- MDR report key
- 9885604
- Report number
- 3004209178-2020-06221
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-17
- Date received
- 2020-03-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA WOODWARD CLARK
- Address
- 7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
- Phone
- 763-763-7635
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | MEDTRONIC PUERTO RICO OPERATIONS CO. | EZW | 3058 | 3058 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-26 | 0 | 1. R |
Event Narratives#
D
Patient 1
NO NEW INFORMATION.
N
Patient 1
THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT #3004209178-2020-06220. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT HAD A BILATERAL SNS DEVICE IMPLANTED FOR SEVERAL YEARS. THE SKIN DIRECTLY ABOVE THE IMPLANTED INS ON THE LEFT SIDE BEGAN TO ERODE OVER THE LAST SEVERAL MONTHS. THE PHYSICIAN SUSPECTS THERE WAS AN ISSUE WITH THE INS THAT CAUSED THE SKIN EROSION AND WOULD LIKE THE DEVICE ANALYZED. THE PHYSICIAN PERFORMED A BATTERY REPLACEMENT PROCEDURE ON THE PATIENT (BOTH LEFT AND RIGHT). UPON DISSECTION, THE PHYSICIAN FOUND A NON-INFECTED SEROMA ABOVE THE BATTERY POCKET. THE PHYSICIAN EXPLANTED THE OLD DEVICES IN QUESTION AND IMPLANTED NEW INS. THE ISSUE WAS RESOLVED. THE FOLLOWING DAY, THE PATIENT CALLED STATING THAT HE HAS 2 INS AND THE ONE ON THE LEFT SIDE STARTED PROTRUDING, SHIFTED, AND TURNED PURPLE. WHEN ASK, THE PATIENT SAID THAT HE HAS MEMORY PROBLEMS AND UNABLE TO PROVIDE ANY TYPE OF TIMEFRAME OF WHEN THIS CHANGE WAS FIRST NOTICED. THE PATIENT SAID THAT HE DIDHAVE A REVISION/REPLACEMENT YESTERDAY AND THEY MOVED THE ONE THAT WAS ON THE LEFT SIDE TO THE OTHER SIDE. THE PATIENT SAID THAT HE DOES NOT HAVE A CURRENT MANAGING DOCTOR AS HIS DOCTOR IS BEING DEPLOYED. THE PATIENT WOULD LIKE AN ADJUSTMENT AND INSISTS THAT THE MANUFACTURER REPRESENTATIVE (REP) HAS TO DO IT HOWEVER, SAID HE DOES NOT HAVE HER NUMBER. THE FIELD CONTACT PRESENT DURING THE REPLACEMENT WAS CONTACTED. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.