FDA Adverse Event
Injury
Summary report: N
ASSURITY SR RF
MDR report key: 5734035
·
Received June 17, 2016
Report
- Report Number
- 2017865-2016-03810
- Event Type
- Injury
- Date Received
- June 17, 2016
- Date of Event
- April 13, 2016
- Report Date
- April 13, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWP
- PMA / PMN Number
- P970013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FINAL ANALYSIS FOUND A LEAKY C4 CAPACITOR WHICH RESULTED IN BATTERY DEPLETION AND HIGH CURRENT DRAIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM FOR UNRELATED REASONS TO THE PACEMAKER. UPON ATTEMPTED INTERROGATION OF THE PULSE GENERATOR, IT COULD NOT BE INTERROGATED. THE PATIENT DID NOT UNDERGO ANY PROCEDURES OR MRI SINCE THE IMPLANT OF THE DEVICE. ON (B)(6) 2016, THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387162 | ASSURITY SR RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | PM1240 | 4748573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |