FDA Adverse Event
Injury
Summary report: N
SIGMA 200 SR
MDR report key: 1923031
·
Received December 13, 2010
Report
- Report Number
- 2647346-2010-00846
- Event Type
- Injury
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S2
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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): PRIMARY ANALYSIS REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD MIGRATED AND WAS CAUSING DISCOMFORT FOR PATIENT. WHILE DOING POCKET REVISION THE PHYSICIAN DECIDED TO CHANGE DEVICE BECAUSE BATTERY INDICATED LESS THAN SEVEN MONTHS REMAINING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGMA 200 SR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | SSR203 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Hospitalization| R | 4092 IMPLANTABLE PACING LEAD |