FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2223856
·
Received August 18, 2011
Report
- Report Number
- 3004209178-2011-06533
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- January 1, 2011
- Report Date
- October 4, 2018
- Manufacturer
- MDTERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT A LEAD REVISION SURGERY ON (B)(6), 2011, DUE TO HIGH IMPEDANCE READINGS. DURING THE PROCEDURE, A NEW LEAD WAS PLACED AND IMPEDANCE MEASUREMENTS OF 0/13 AND 0/14 WERE GREATER THAN 10,000 OHMS. THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS, THEN, REMOVED AND REPLACED. NO PT SYMPTOMS WERE PROVIDED. SEE MFR REPORT # 3004209178201106535 FOR INFO RELATED TO THE SUBSEQUENTLY IMPLANTED NEUROSTIMULATOR, ASSOCIATED EVENTS DURING THE SAME SURGICAL PROCEDURE, AND PT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDTERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention | EXPLANTED.| EXPLANTED: | EXPLANTED: | IMPLANTED.| IMPLANTED: | IMPLANTED: | LEAD: MODEL 39565-65, LOT # V582460011.| LEAD: MODEL 39565-65, LOT# V402369005.| LEAD: MODEL UNK, LOT# UNK.| PROGRAMMER: MODEL 37743, LOT# NKE143159N.| RECHARGER: MODEL 37752, LOT# NKA137455N.| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE143159N| RECHARGER: MODEL 37752, LOT# NKA137455N| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V402369005| EXPLANTED:| IMPLANTED:| LEAD: MODEL UNK, LOT# UNK |