FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGABLE
MDR report key: 2193609
·
Received July 14, 2011
Report
- Report Number
- 3004209178-2011-05455
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 21, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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 DURING IMPLANT, THE PHYSICIAN THOUGHT THE INSULATION OF THE LEAD HAD BEEN CUT. HE WAS ALSO HAVING DIFFICULTY PLACING THE LEAD AND CHANGING STYLETS. HE CHANGED TO A CURVED-TIP NEEDLE AND ATTEMPTED TO CHANGE THE STYLET BUT COULDN'T. THE PHYSICIAN PULLED THE LEAD OUT OF THE NEEDLE AND ATTEMPTED TO THREAD THE STYLET BUT WAS UNABLE TO. WHEN HE EXAMINED THE LEAD IT APPEARED TO BE BROKEN. 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 RECHARGABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | PROGRAMMER: MODEL 37743, LOT # NKE167405N| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA150824N| EXPLANTED:| LEAD: MODEL 3778, LOT # V696210013| LEAD: MODEL 3778, LOT # V564235009 |