MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-24 for ACTIVA 3391-28 manufactured by Mpri.
[68281125]
Product id: 3391-28, lot# 0211891335, implanted: (b)(6) 2017, product type: lead.
Patient Sequence No: 1, Text Type: N, H10
[68281126]
A health care provider (hcp) reported via a manufacturer representative that there was an issue with the length of two leads during implant. The leads were normally 28 cm long with a variation of +/- 1 mm, but the leads had a variation of 1 cm. The leads were 1 cm shorter than expected. The leads were not able to be directed to the target, so the hcp had to find a way to do so. Troubleshooting and intervention included lowering the leksell tool holder to make sure the leads were at the target. The cause of the event was unknown. The leads were able to be implanted and they were doing fine. The manufacturer representative was waiting for more information about clinical efficacy. The issue was resolved at the time of this report. The patient's indication for use is obsessive compulsive disorder. The patient was alive with no injury. Refer to manufacturer report #2649622-2017-02436.
Patient Sequence No: 1, Text Type: D, B5
[95767266]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2649622-2017-02437 |
| MDR Report Key | 6357056 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-24 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2017-02-22 |
| Device Manufacturer Date | 2016-06-02 |
| Date Added to Maude | 2017-02-24 |
| 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 | LISA CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MPRI |
| Manufacturer Street | ROAD 149 KM 56.3 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVA |
| Generic Name | DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER |
| Product Code | MFR |
| Date Received | 2017-02-24 |
| Model Number | 3391-28 |
| Catalog Number | 3391-28 |
| Lot Number | 0211891334 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MPRI |
| Manufacturer Address | ROAD 149 KM 56.3 VILLALBA PR 00766 US 00766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-24 |