MAUDE Adverse Event Report: ST. JUDE UNKNOWN ANS RECHARGER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problems Break (1069); Failure to Charge (1085)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

The patient reported that a prong broke on their recharger.The patient also reported that because they were not able to recharge, they had a return of symptoms and felt a fiery pain down their leg.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN ANS RECHARGER
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17535421
• MDR Text Key: 321066069
• Report Number: MW5142318
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1