MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-07-23 for DBS 3389 NA manufactured by Medtronic Puerto Rico Operations Co., Mpri.
[329385]
Hcp reported blurred vision in 2003 above 1. 1 volts on #3 contact and at lower volts on #0, #1, #2 contact on right brain lead. Hcp reported pain at connection behind left ear and scalp in 2004. The right brain device was turned off and the blurred vision improved. No fracture found for left lead. The right brain lead was replaced and the outcome is pending. The left extension was replaced with resolution of pain. Post-op mri showed left lead in different position from initial post-op film and the right brain lead still in poor position for benefit. The right brain lead was explanted and returned to the mfr for analysis. A follow-up report will be sent when add'l info is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000153-2004-00938 |
| MDR Report Key | 536068 |
| Report Source | 05 |
| Date Received | 2004-07-23 |
| Date of Report | 2004-07-12 |
| Date of Event | 2004-04-28 |
| Date Mfgr Received | 2004-07-12 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2004-07-28 |
| 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 | BARBARA PAHL |
| Manufacturer Street | 710 MEDTRONIC PARKWAY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050856 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS |
| Manufacturer Street | ROAD #149, KM. 56.3, CALL BOX 6001 |
| 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 | DBS |
| Generic Name | LEAD |
| Product Code | GYZ |
| Date Received | 2004-07-23 |
| Returned To Mfg | 2004-07-12 |
| Model Number | 3389 |
| Catalog Number | NA |
| Lot Number | J0340291V |
| ID Number | NA |
| Device Expiration Date | 2007-08-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 525317 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO., MPRI |
| Manufacturer Address | RD. 149, KM. 56.3 CALL BOX 6001 VILLALBA PR 00766 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | LEAD |
| Baseline Model No | 3389 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-07-23 |