FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1926396
·
Received November 11, 2010
Report
- Report Number
- 3004209178-2010-09253
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- October 25, 2010
- Report Date
- October 25, 2010
- 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD AN ALLERGIC REACTION TO THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PT HAD A SPECIAL COATING FOR THE INS. THE PT WAS HAVING TROUBLE BREATHING AND WAS UNCERTAIN WHETHER THIS WAS CAUSED BY THE SPECIAL COATING. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 57 YR | IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE146036N| EXPLANTED:| LEAD: MODEL 3487A, LOT# V260569| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB002428V| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA127675N| LEAD: MODEL 3778, LOT# V269718032| EXPLANTED:| LEAD: MODEL 3487A, LOT# V260569 |