MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION 3522 RF TRANSMITTER; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 3522

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Information related to the lead is captured in regulatory report number 3007566237-2016-02612.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient had a stimulator placed in 1982.At an appointment on (b)(6) 2016, the patient reported it did not work and it was not a rechargeable battery.The hcp did not have any indication of when the stimulator began not working.On (b)(6) 2016, the hcp did a revision of the leads and generator.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp).The patient weight was provided.No further complications were reported.

• Brand Name: 3522 RF TRANSMITTER
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7151178
• MDR Text Key: 95932472
• Report Number: 3007566237-2017-05329
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3522
• Device Catalogue Number: 3522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 02/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 89