N
Patient 1
DATE OF EVENT AND THERAPY DATES ARE ESTIMATED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
MAUDE MDR 9884222
- MDR report key
- 9884222
- Report number
- 1627487-2020-03165
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-08-09
- 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
- ANDREA DEITZ
- Address
- 6901 PRESTON ROAD PLANO TX 75024 US
- Phone
- 972-972-9723
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INFINITY? 5 IMPLANTABLE PULSE GENERATOR | DBS IPG | ST. JUDE MEDICAL - NEUROMODULATION | MHY | 6660 | 6660 | 6553742 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-26 | 0 | 1. O |
Event Narratives#
D
Patient 1
RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-03166; 1627487-2020-03167; 1627487-2020-03168. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN AN UNKNOWN LOCATION. AS A RESULT, THE SYSTEM WAS EXPLANTED. THE INFECTION HAS SINCE RESOLVED, AND THE PATIENT WAS RE-IMPLANTED AT A LATER DATE.
N
Patient 1
DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN PATIENT WEIGHT, BUT IT COULD NOT BE OBTAINED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED DEVICE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.