MAUDE Adverse Event Report: MEDTRONIC INC. PULSE GENERATOR, PERMANENT, IMPLANTABLE; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Device Problems Break (1069); Charging Problem (2892)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2013

Event Type  malfunction  

Event Description

Boston scientific neuromodulation (bsn) received information about an event on (b)(6) 2013 that would have been reportable under 21 cfr 803, medical device reporting within our complaint system.However, the issue reported was related to a medtronic paddle lead and ipg.The information received stated that the patient's medtronic lead was explanted due being broken and the ipg was explanted due to difficulty charging.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 17532375
• MDR Text Key: 321432987
• Report Number: MW5139283
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 12/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Treatment: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAI