FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2093999
·
Received May 13, 2011
Report
- Report Number
- 3004209178-2011-03514
- Event Type
- Injury
- Date Received
- May 13, 2011
- Date of Event
- March 1, 2010
- Report Date
- April 27, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT EXPERIENCED DIFFICULTY RECHARGING HIS DEVICE. HE WAS UNABLE TO GET MORE THAN 2 SHADED COUPLING BARS. HOW TO RECHARGE WAS REVIEWED WITH THE PATIENT BY THE MANUFACTURER'S PATIENT SERVICES. PATIENT WAS REDIRECTED TO HIS PHYSICIAN. PATIENT REPORTS THE ANTENNA JACK HAD MISSING PLASTIC INSIDE. THE BROKEN PIECE WAS REPLACED BY THE MANUFACTURER. ADDITIONAL INFORMATION FROM THE PHYSICIAN REPORTED THE INS WAS FLIPPED. A REVISION WAS DONE ON (B)(6) 2010, REPOSITIONING THE INS IN THE POCKET. AFTER SURGERY THE PATIENT HAD SATISFACTORY RESULTS AND RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | H0268661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention | PROGRAMMER: MODEL 37743, LOT# NKE141901N| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V402369001| IMPLANTED:| RECHARGER: MODEL 37752, LOT# NKA135856N |