N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 7476205
- MDR report key
- 7476205
- Report number
- 3007566237-2018-01301
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-04-27
- Date received
- 2018-05-01
- 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 | ACTIVA | DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER | MEDTRONIC NEUROMODULATION | OLM | 3391 | 3391 | UNKNOWN | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-01 | 0 |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED DURING THE PROCEDURE THE PHYSICIAN IMPLANTED THE LEAD THEN CHANGED HIS MIND AND DECIDED TO USE A DIFFERENT LEAD INSTEAD. UPON EXPLANT, THE PHYSICIAN NOTICED ONE OF THE CONTACTS APPEARED TO BE DAMAGED UPON VISUAL INSPECTION. THE PHYSICIAN DECIDED NOT TO USE THE IMPLANT BEFORE THE DEFECT WAS NOTICED. THE PRODUCT WAS REPLACED. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS WERE THOUGHT TO HAVE LED TO OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT AND NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
N
Patient 1
ANALYSIS OF THE LEAD (LOT # UNKNOWN) REVEALED NO SIGNIFICANT ANOMALY: STIM LEAD/BODY/CONDUCTOR CRUSHED. HOWEVER, ELECTRICAL TESTING DETERMINED THAT CONTINUITY WAS COMPLETE AND THERE WERE NO ELECTRICAL SHORTS BETWEEN THE CIRCUITS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.