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

Model Number 97712

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Material Integrity Problem (2978)

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

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 97754, serial# (b)(4), product type: recharger.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 about a patient implanted with an implantable neurostimulator (ins) for spinal pain.The patient reported that their recharger was not working as they were getting poor coupling intermittently.The patient stated that they tried repositioning the antenna many times and charging on bare skin.He mentioned that he charges every day and does not normally use the recharging belt.Trouble shooting using antenna locate did not resolve the issue and the patient was instructed to follow up with their health care provider for support.There were no patient symptoms were reported.No further patient complications have been reported as a result of this event.

Event Description

No patient symptoms were reported.

Manufacturer Narrative

Analysis of the desktop charger found that it had a broken connector pin.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep reported that they jump started the patient's battery and that the patient received the replacement desktop charger cord and is no doing fine.No further complications were reported.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id (b)(4) lot# serial# (b)(6) implanted: explanted: product type recharger product id (b)(4) lot# serial# (b)(4) implanted: explanted: product type recharger if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that connector pin on desktop charger was loose/broken and was moving around and patient couldn't get any charge on their ins recharger.It was also reported that battery was dead and rep had to jump start it.It was stated that this desktop charger was a replacement received and it worked for a little while but then died and patient couldn't charge.No patient symptoms reported.No further complications were reported as a result of this event.[refer to pe 701731073 for details pertaining to the previously reported broken connector pin].

Manufacturer Narrative

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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6578150
• MDR Text Key: 75548175
• Report Number: 3004209178-2017-10658
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• 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: 68 YR