FDA Adverse Event
Injury
Summary report: N
PRODIGY IPG
MDR report key: 7075296
·
Received December 1, 2017
Report
- Report Number
- 1627487-2017-07901
- Event Type
- Injury
- Date Received
- December 1, 2017
- Report Date
- January 8, 2018
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 1 OF 2. REFERENCE MFR. REPORT# 1627487-2017-07902. THE PATIENT HAS 2 IPGS. IT WAS REPORTED ((B)(6)) THE PATIENT DID NOT CHARGE THE IPG¿S AS RECOMMENDED. AS A RESULT, THE DEVICES DEEMED INOPERABLE. AS A RESULT SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED.
Description of Event or Problem · 1
DEVICE 1 OF 2, REFERENCE MFR. REPORT# 1627487-2017-07902. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE ISSUE HAS RESOLVED.
Description of Event or Problem · 1
DEVICE 1 OF 2. REFERENCE MFR. REPORT# 1627487-2017-07902.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 855449 | PRODIGY IPG | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3799 | 4997913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other |