FDA Adverse Event
Injury
Summary report: N
SCREW-IN
MDR report key: 2812969
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-17202
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K902002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION AND THE DEVICE MET EXPECTED LONGEVITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD REACHED BATTERY DEPLETION EARLY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THE LEFT VENTRICULAR LEAD HAD LOW R WAVES AND HIGH THRESHOLD. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW-IN | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R | 3889 INTERSTIM LEAD| 5076 IMPLANTABLE PACING LEAD| 3023 INTERSTIM IMPLANTABLE PULSE GENERATOR| 3095 NEURO EXTENSION| 6947 IMPLANTABLE TACHY LEAD |