N
Patient 1
DATE OF EVENT IS ESTIMATED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT INFORMATION. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
MAUDE MDR 9908210
- MDR report key
- 9908210
- Report number
- 1627487-2020-03491
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-01
- Date received
- 2020-03-31
- 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 | PRODIGY MRI IPG, 16CH, RECHARGEABLE | SCS IPG | ST. JUDE MEDICAL - NEUROMODULATION | LGW | 3772 | 3772 | 5882950 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED THE PATIENT WAS UNABLE TO CHARGE THE IPG JUST PRIOR TO A LEAD REVISION (PLEASE SEE REFERENCE MFR REPORT#: 1627487-2020-02686), AND IPG WOULD NOT COMMUNICATE WITH OTHER EXTERNAL DEVICES, EITHER. FURTHER INFORMATION REVEALED THE PATIENT LAST RECHARGED THE IPG IN (B)(6) 2019, AND LAST HAD STIMULATION IN (B)(6) 2019, BUT EXACT DATES ARE UNKNOWN. TO ADDRESS THE ISSUE, THE PHYSICIAN EXPLANTED AND REPLACED THE IPG WITH A NEW MODEL, WHICH RESOLVED THE ISSUE.
N
Patient 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.