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

Model Number	97714
Medical Device Problem Codes	Failure to Power Up (1476); Charging Problem (2892); Connection Problem (2900); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 97714, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 37761, serial# unknown, product type: recharger.Other relevant device(s) are: product id: 37761, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received regarding a patient implanted with a neurostimulator (ins) used for non-malignant pain.Consumer reported the desktop charger (dtc) wouldn't stay plugged into the recharger (insr).It was reported that the cord would fall out/was broken.No further complications reported/anticipated.03/08/2019 (b)(4) (rep): additional information from representative was received.Rep stated patient still had issues with connector pin not staying in recharger, and recharger would not turn on, patient could not charge ins to use therapy for neck.At first, it sounded like it was the same issue as initial call.After reviewed of notes, repair said replacement for desktop charger was never sent.A replacement patient programmer would be sent.It was mentioned desktop charger connector pin was broken off, and pp would not power up right.No further complication and events were reported.
Additional Manufacturer Narrative
Continuation of concomitant products: product id: 97740, serial# (b)(4), product type: programmer, patient product id: 37761, serial#: unknown, product type: recharger.The initial mdr was filed as mfg.Report # 2182208-2019-00492.Additional review indicated that the correct manufacturing site was site # 3004209178.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• MDR Report Key: 8408224
• Report Number: 2182208-2019-00492
• Device Sequence Number: 269131
• Product Code: LGW
• UDI-Device Identifier: 00643169518919
• UDI-Public: 00643169518919
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 04/08/2019; 05/10/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/23/2019; 05/10/2019; 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR