FDA Adverse Event
Injury
Summary report: N
ACTIVA RC
MDR report key: 2113737
·
Received June 2, 2011
Report
- Report Number
- 3007566237-2011-03905
- Event Type
- Injury
- Date Received
- June 2, 2011
- Report Date
- May 4, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS CONFIRMED TO HAVE FLIPPED. THE DEVICE WAS PLACED IN THE PT'S ABDOMEN, AS THE PT WAS UNABLE TO USE THE HARNESS. THE DEVICE FLIPPED DUE TO TISSUE PUSHING UP ON IT WHEN THE PT SAT. THE PHYSICIAN MADE A POUCH AND CUT OUT THE AREA OF THE RECHARGE COIL. NO PT SYMPTOMS OR INJURY WERE REPORTED. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADDITIONAL INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA RC | MHY | MEDTRONIC NEUROMODULATION | 37612 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |