MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 37761, serial# (b)(4), product type: recharger.Analysis of the desktop charger determined that there were broken connector pins on the cable assembly.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with a neurostimulator for spinal pain.It was reported that there was a broken connector pin on the desktop charger and that the implantable neurostimulator battery was ¿totally run down¿ (clarified as low battery) and that the patient could not feel stimulation.The patient was able to connect with the patient programmer, so the patient was not in overdischarge, but the ins battery icon on the patient programmer indicated low battery.The patient experienced pain in the back and hips as a result of the lack of stimulation.The patient recharged to resolve the lack of stimulation and also learned how to stop stimulation.The lack of stimulation had been resolved as of (b)(6) 2016.

Manufacturer Narrative

Evaluation conclusion code no longer applies.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5660487
• MDR Text Key: 45324313
• Report Number: 3004209178-2016-09644
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2016

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 Expiration Date: 06/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided; 05/17/2016
• Supplement Dates FDA Received: 05/18/2016; 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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: 58 YR