FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2230550
·
Received August 12, 2011
Report
- Report Number
- 3004209178-2011-06309
- Event Type
- Injury
- Date Received
- August 12, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 19, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REJECTING. THE PT INDICATED HE STARTED TO FORM A BLOOD BLISTER UNDER THE DEVICE. THE BLOOD BLISTER POPPED AND THE WOUND DID NOT HEAL. THE STIMULATOR WAS REPORTEDLY 1/4 AN INCH OUT OF THE PT'S BODY. THE PT WAS CLEARED OF AN INFECTION AT THE HOSP AND WANTED THE DEVICE EXPLANTED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | LEAD: MODEL 3778, LOT# V041871032| EXTENSION: MODEL 37081, LOT# NJB015671V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 388, LOT# V033673| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V040902| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB012523V| EXPLANTED:| EXPLANTED:| IMPLANTED: |