MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)

Patient Problems Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 02/12/2010

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient implanted with a neurostimulator (ins) for obsessive compulsive disorder.It was reported that since implant the patient has experienced little jolts here and there.It was also reported that it has taken a long time recharge the device since implant.It was stated the patient was not feeling stimulation and usually does not feel it.It was reported that the patient has never really felt stimulation since implant.No further complications were reported.

Event Description

Additional information was received.It was reported that the patient's healthcare professional (hcp) hadn't seen the patient since implant.It was noted that the hcp would have a manufacturer representative (rep) contact the patient.

Event Description

Follow up information received from the patient reported that periodic jolting still occurs, which they assume is from the implant.It was also noted that it still takes longer to charge but that is because settings are high.No further complications are anticipated.

Manufacturer Narrative

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

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• 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: 6380459
• MDR Text Key: 69166020
• Report Number: 3007566237-2017-00864
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR