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); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 02/04/2015

Event Type  malfunction  

Manufacturer Narrative

Main component of the system and other applicable components are: product id 37761, serial # (b)(4), product type recharger; product id 97740, serial # (b)(4), product type programmer, patient; product id 97754, serial # (b)(4), product type recharger; product id 39286-65, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 37761, serial # (b)(4), product type recharger.Analysis of the 37761 desktop charger (serial #: (b)(4)) found a broken connector.

Event Description

Information was received from a patient regarding their implantable neurostimulator for non-malignant pain.It was reported that the implantable neurostimulator recharger (insr) was not charging and the connector pin was loose.The patient's hand was in pain because she had not been able to use stimulation for the last 2 days.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, the event will be updated.Upon device return, analysis found the cable assembly had broken connector pins.

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: 5586974
• MDR Text Key: 43017382
• Report Number: 3004209178-2016-07728
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

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: 05/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 04/19/2016
• Supplement Dates Manufacturer Received: 02/06/2015
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• 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: 00030 YR